PharmaMar’s Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) has obtained another three approvals as first-line maintenance therapy for small cell lung cancer

Australia, Singapore and the Dominican Republic are the latest countries to adopt the approvals for commercialization. The treatment is now available in 13 countries. PharmaMar (MSE:PHM) has announced that the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority (HSA) in Singapore have granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. The approvals are based on the results from the Phase 3 IMforte[i]trial. PharmaMar’s partner in Australia and Singapore, Specialised Therapeutics Asia Pte, Ltd (STA), will market and commercialize the product. These approvals were obtained under the Orbis Project, an initiative of the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence, designed to provide a framework for concurrent submission and review of oncology products among international partners. As of today, this treatment is approved in a total of 13 countries: the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel, Taiwan, Australia, Singapore and Dominican Republic. PharmaMar also received a recommendation for approval from the European Medicines Agency in March. The European Commission will now decide on the marketing authorization in accordance with the established procedure. i Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial – The Lancet

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